Инструкция по применению ANTROLIN
ANTROLIN 0.3% + 1.5% rectal cream
ATC code: C05AX - Nifedipine + Lidocaine
Tube containing 30 g
COMPOSITION
100 g of cream contain:
Active ingredients: Nifedipine g 0.3 - Lidocaine hydrochloride g 1.5 –
Excipients: White petrolatum, Propylene glycol, Liquid semi-synthetic triglycerides,
Stearyl polyethylene glycol, Cetyl alcohol, Glyceryl monostearate, Sodium methyl p-hydroxybenzoate,
Propyl p-hydroxybenzoate, Purified water.
PHARMACEUTICAL FORM AND CONTENT
Rectal cream. Aluminum tube containing 30 g, with cannula, in a cardboard box.
PHARMACOTHERAPEUTIC CATEGORY
Medicinal product containing nifedipine, a dihydropyridine with calcium antagonist action which, when
used locally, exerts a relaxing effect on peripheral smooth muscle and is able to reduce the
tone of the internal anal sphincter. The action of nifedipine is integrated in the product by the
presence of lidocaine, a local surface anesthetic.
HOLDER OF THE MARKETING AUTHORIZATION
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15
- 20143 - Milan
PRODUCER AND FINAL CONTROLLER
New.Fa.Dem srl Pharmaceutical and Chemical Company with registered office and production facility in Viale Ferrovie
dello Stato, Area A.S.I. Giugliano in Campania NA
THERAPEUTIC INDICATIONS
Treatment of anal fissure and proctalgia in general associated with anal sphincter hypertonia.
CONTRAINDICATIONS
Hypersensitivity to the active ingredients and in particular to lidocaine (and other local anesthetics with
similar amidic structure) or to any of the excipients.
Confirmed or suspected pregnancy and breastfeeding (see also "Special warnings").
Severe hypotension and cardiovascular insufficiency.
PRECAUTIONS FOR USE
During clinical trials, no adverse effects resulting from possible systemic absorption of the drug have been reported. ANTROLIN rectal creamshould nevertheless be
used with extreme caution in patients who have severely damaged mucous membranes and inflammation in
the area to be treated, as excessive absorption of the
active ingredients could occur in such situations. The medicinal product should also be used with caution in diabetic patients or in
those with severe hepatic and/or renal insufficiency.
Treatment with ANTROLIN rectal creamshould be carried out under medical supervision in
very elderly patients, as well as in those under 18 years of age and in patients undergoing
treatment with Beta-blockers or antihypertensive drugs.
It is advisable to monitor blood pressure at the beginning and periodically during treatment.
In case of treatment failure (no improvement or worsening of symptoms)
it is necessary to discontinue treatment and consult a doctor for other measures.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS
Due to the presence of nifedipine, the effect of antihypertensive drugs may be potentiated by the use
of ANTROLIN rectal cream. Propranolol prolongs the plasma half-life of lidocaine and
increases plasma levels of nifedipine. Cimetidine can increase plasma levels of
lidocaine and nifedipine. The simultaneous administration of ANTROLIN rectal creamin
patients treated with digoxin may lead to an increase in plasma levels of digoxin.
SPECIAL WARNINGS
Topical application of the medicinal product in excessive doses and/or for prolonged periods of time may give
rise to sensitization phenomena and local reactions of hyperemia and bleeding, which
disappear upon discontinuation of treatment.
Use in pregnancy and during breastfeeding
Nifedipine and lidocaine cross the placental barrier and are excreted in breast milk.
In studies conducted on rats and rabbits, nifedipine has been shown to be able to cause
teratogenic effects. Lidocaine has not shown any risks to the fetus. However, it is recommended not to
use the product in pregnant and breastfeeding women.
Warnings relating to certain excipients present in the medicinal product
ANTROLIN rectal creamcontains sodium methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which
may cause allergic reactions, even delayed ones. Furthermore, ANTROLIN rectal creamcontains
propylene glycol and cetyl alcohol which may cause local skin reactions (e.g., contact dermatitis).
T .
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT:
For endorectal and perianal applications.
Apply the cream twice a day for at least three weeks.
Method of administration
- Lie on your left side on the bed;
- unscrew the cap from the tube and screw on the cannula ,squeeze out a small amount of cream to lubricate the cannula and insert it into the anus;
- press the end of the tube, squeeze out the cream contained in about one centimeter of the tube (one centimeter of the tube contains approximately 2.5 - 3 g of cream).
OVERDOSAGE
No cases of systemic toxicity from overdose after topical application of
ANTROLIN rectal creamhave been reported. In the event of intoxication after topical application of
the product, the systemic effects should be similar to those induced by the active ingredients with other
routes of administration.
In cases of severe intoxication from Nifedipine, disturbances of consciousness up to
coma, a drop in blood pressure and alteration of heart rhythm and cardiogenic shock may occur. For
treatment, beta-sympathomimetics can be used for bradycardic disturbances of heart rhythm and, in case of severe hypotension, calcium gluconate (10-20 ml of
10% solution slowly intravenously) and possibly dopamine or norepinephrine.
Most of the toxic reactions to local anesthetics and lidocaine in humans affect the
CNS; a feeling of "lightheadedness" and dizziness is felt, often followed by visual and
auditory disturbances, such as difficulty accommodating and tinnitus, and in more severe cases, CNS depression and
convulsions. Treatment is symptomatic.
UNDESIRABLE EFFECTS
Locally, reactions such as pain, burning, itching, hyperemia and bleeding may occur.
These effects resolve after discontinuation of treatment.
In very rare cases, local application of preparations based on lidocaine has caused allergic reactions (in the most severe cases anaphylactic shock).
During the clinical trial phase, no adverse effects due to possible systemic absorption of the two active ingredients (headache, dizziness, peripheral vasodilation,
hypotension, dizziness and tremors) have been detected.
Undesirable effect with unknown frequency: difficulty breathing.
Inform your doctor or pharmacist of any adverse effects here
not described or unexplainable.
EXPIRY DATE AND STORAGE:
Check the expiry date indicated on the packaging
Store in a tightly closed container; store at a temperature not exceeding 25°C.
The expiry date refers to the product in intact packaging, correctly
stored.
The validity of the product after first opening is 30 days (write the date of first opening
in the appropriate space on the packaging)
WARNING: Do not use the medicinal product after the expiry date indicated on the
packaging and after 30 days from first opening
Keep the medicinal product out of the reach of children
HEALTH:

- Страна регистрации
- Форма выпускаRectal cream, 0.3% + 1.5%
- Код АТХC05AX03
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги ANTROLINФорма выпуска: Cream, 1% + 1.5%Действующее вещество: ГидрокортизонОтпускается без рецептаФорма выпуска: Rectal cream, 0,1 MG/G + 10 MG/GДействующее вещество: Флуоцинолон ацетонидПроизводитель: RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.Отпускается без рецептаФорма выпуска: Cream, 20 GДействующее вещество: ГидрокортизонПроизводитель: KARO HEALTHCARE ABОтпускается без рецепта
Аналоги ANTROLIN в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог ANTROLIN в Польша
Аналог ANTROLIN в Украина
Аналог ANTROLIN в Испания
Врачи онлайн по ANTROLIN
Обсудите применение ANTROLIN и возможные следующие шаги — по оценке врача.
Получите рецепт на ANTROLIN онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
ANTROLIN требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ANTROLIN — other preparations, combinations. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ANTROLIN производится компанией NEOPHARMED GENTILI S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения ANTROLIN с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить ANTROLIN в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (other preparations, combinations) включают EMORRIL, PROKTOLYN, PROKTOSEDYL. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















